Absorbable vs Permanent Sutures for Umbilical Hernia

(PAPYRUS Trial)

Not yet recruiting at 4 trial locations

Overseen By Rachel Liu Hennessey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Pregnancy, BMI ≥ 35, Immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: Immediate (surgery)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether absorbable or permanent sutures better prevent umbilical hernia recurrence. Umbilical hernias are small gaps in the abdominal wall near the belly button. The study will evaluate which type of suture promotes optimal healing while minimizing complications. Participants who require elective surgery for a primary umbilical hernia of 2 cm or smaller are suitable candidates. The trial will also monitor post-surgery complications and quality of life. Results could transform hernia treatment worldwide. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that may enhance hernia treatment globally.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that absorbable stitches offer some benefits in hernia repairs. They can reduce the risk of wound infections and may promote better healing. However, the chance of hernia recurrence can reach up to 27% with these stitches, although one study found a recurrence rate of about 9.8%.

Permanent stitches, often made from polypropylene, are known for their strength. Some research has examined their use with mesh repairs, revealing a complication rate of about 33.3% in certain cases. These studies, however, involved more complex repair methods than using stitches alone.

Both absorbable and permanent stitches have advantages and disadvantages. Absorbable stitches may be gentler on the body, while permanent ones offer greater strength. Overall, both types are generally considered safe, but each carries its own risks for complications and hernia recurrence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for umbilical hernia repairs because they offer potential advantages over traditional sutures. Absorbable sutures, like those made from polydioxanone, dissolve naturally in the body over time, which might reduce the need for follow-up surgeries to remove them. This can minimize complications related to foreign materials being left in the body. Meanwhile, permanent sutures, such as those made from polypropylene, are known for their long-lasting strength and durability, which can be crucial for maintaining repair integrity in the long term. These options give doctors and patients more flexibility in choosing the best fit for individual healing needs.

What evidence suggests that this trial's treatments could be effective for umbilical hernia repair?

This trial will compare absorbable sutures with permanent sutures for umbilical hernia repair. Research has shown that the type of stitches used in umbilical hernia repair can affect the likelihood of the hernia returning and other post-surgery issues. Participants may receive absorbable stitches, which dissolve over time and might reduce the risk of wound infection and aid healing, though the recurrence rate compared to permanent stitches remains unclear. Alternatively, participants may receive permanent stitches, which remain in the body and might be stronger and more effective at keeping the hernia closed. Some studies have found that hernias can return in 4% to 15% of cases, depending on the type of stitches and other factors. Both types of stitches are used for their distinct advantages, and ongoing research seeks to determine which is better in the long term. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with small umbilical hernias requiring repair surgery. Participants should be suitable for suture-only repair without mesh and willing to follow up over a 2-year period post-surgery. Specific inclusion or exclusion criteria are not provided, but typically these would relate to overall health, age, and the specifics of their hernia.

Inclusion Criteria

Patient able to give oral and written informed consent

I am scheduled for surgery on a small hernia (2 cm or less) in my belly button.

I am older than 18 years.

Exclusion Criteria

Pregnancy

Immunosuppression

Patient deemed unfit for primary repair at time of surgery based on surgeon discretion at time of operation (e.g. poor tissue quality or unexpected operative finding)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary repair of umbilical hernias using either absorbable polydioxanone suture or permanent polypropylene suture

Immediate (surgery)

1 visit (in-person)

Follow-up

Participants are monitored for recurrence, SSO, SSOPI, and quality of life at 30 days, 12 months, and 24 months post-surgery

24 months

Multiple visits (in-person and virtual) at 30 days, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Absorbable
• Permanent Suture

Trial Overview The study compares two types of sutures in umbilical hernia repairs: absorbable polydioxanone suture versus permanent polypropylene suture. It aims to see which one leads to lower recurrence rates, fewer complications, and better quality of life after surgery.

How Is the Trial Designed?

Group I: Permenant Suture Active Control 1 Intervention

Repair with permanent 0-0 polypropylene suture.

Group II: Absorbable Suture Active Control 1 Intervention

Repair with an 0-0 polydioxanone suture

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

North York General Hospital

Collaborator

Trials

22

Recruited

8,800+

Royal Victoria Hospital Of Barrie

Collaborator

Trials

2

Recruited

80+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07156188

The PAPYRUS Study: Permanent vs. Absorbable Sutures ... Suture type may play a role in reducing risk of recurrence and post-operative complications following primary suture repair of umbilical hernia. There have been ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7260408/

Mesh versus suture in elective repair of umbilical hernia The study found significantly decreased recurrence rates following mesh versus suture repair in ventral hernias of up to 1 cm and in those of more than 1 to 2 ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05366-7

mesh versus suture repair in small umbilical hernias in adults ... These limited retrospective hand-full published studies reported recurrence rates for suture repair of 4–15% compared to much lower rates for ...

4. academic.oup.com academic.oup.com/bjsopen/article/9/1/zrae173/8046902

Onlay mesh versus suture repair for smaller umbilical hernias ... Mesh repair is recommended for umbilical hernias larger than 1 cm to reduce recurrence rates, yet current evidence remains limited for smaller umbilical ...

5. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2599143

Factors Associated With Long-term Outcomes of Umbilical ... The primary suture repair recurrence rate was 9.8% (16 of 163 patients), and the mesh repair recurrence rate was 2.4% (4 of 169 patients).

6. link.springer.com link.springer.com/article/10.1007/s00464-025-12212-3

Primary umbilical hernia repair: does suture type matter? Umbilical hernias 2 cm or less are generally treated with open primary suture repair with associated risk of recurrence up to 27 percent. A ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5831449/

Factors Associated With Long-term Outcomes of Umbilical ... The primary suture repair recurrence rate was 9.8% (16 of 163 patients), and the mesh repair recurrence rate was 2.4% (4 of 169 patients).

8. sciencedirect.com sciencedirect.com/science/article/pii/S0039606025006300

Slowly absorbable sutures do not increase the risk of ... Based on our data, we cannot conclusively determine that fast-absorbable sutures are safe for primary ventral hernia repair with or without mesh. We ...